2016 End-of-Year Summary of FDA Advertising and Promotion Enforcement Activity

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Food, Drugs, and Devices Celator Untitled Letter (August 2016) As part of its monitoring and surveillance program, OPDP saw a panel posted by Celator in the main exhibit hall at the American Society for Clinical Oncology Annual Meeting. According to OPDP, the panel promoted Celator’s investigational product, CPX-351 (Cytarabine; Daunorubicin) Liposome Injection (CPX-351). OPDP found that the panel suggested that CPX- 351 was safe and effective for the purposes for which it was being investigated. Misbranding of an Investigational Drug: The panel promoted the drug with statements such as “VYXEOS [the intended proprietary name of CPX-351] . . . delivers optimal anti-cancer activity” and “A completed Phase 3 study demonstrated improved survival for VYXEOS compared to ‘7+3’ in newly diagnosed patients with high-risk AML.” OPDP alleged that this claim suggested that CPX-351 was effective for treatment of cancer generally and improves survival relative to “7+3” chemotherapy. OPDP further criticized the “use of a proprietary name without any accompanying identification of the investigational drug product.” Finally, OPDP noted that the panel appeared in the main exhibit hall, “alongside approved products” but failed to include information to indicate that CPX- 351 was an investigational drug product. For these reasons, OPDP concluded that CPX-351 was misbranded. DURECT Untitled Letter (September 2016) OPDP found that website presentations of Remoxy (oxycodone) Extended-Release Capsules (Remoxy ER) suggested that the drug was safe and effective for the purposes for which it was being investigated. Misbranding of an Investigational Drug: Specifically, OPDP objected to the Durect website’s presentation of information about Remoxy ER on a rotating basis with information about other products. OPDP noted that statements about the drug on the page (such that it was “longacting” and “tamper-resistant”) were phrased as established facts, thereby suggesting the drug is safe and effective with the characteristics described. Clicking on any part of the Remoxy ER presentation on the Durect website linked directly to a specific product webpage devoted to Remoxy ER. The webpage included various “Potential Benefits,” including that the formulation of the drug was designed to deter abuse and that it provides “long-term pain control” of “moderate-to-severe chronic pain.” Additionally, nothing in the website’s presentation disclosed that the drug was an investigational new drug. Although the Rempoxy ER product webpage stated that the product is “IN DEVELOPMENT” and stated a target action date under the Prescription Drug User Fee Act (PDUFA), OPDP stated that these indirect statements did not adequately convey that the product is unapproved or sufficiently mitigate the impression that Remoxy ER is safe and effective for moderate-to-severe chronic pain and has properties to deter abuse. Supernus Untitled Letter (October 2016) OPDP alleged that a “Key Opinion Leader” Spanish-language video for Oxtellar XR (oxcarbazepine) extended-release tablet for oral use (Oxtellar XR) made false or misleading representations about the risks associated with the drug. 10
Food, Drugs, and Devices Lack of Adequate Directions for Use: OPDP noted that Oxtellar XR is intended to treat only partial seizures in adults and in children six to 17 years of age but that the video used general terms such as “epilepsy” and “convulsive.” OPDP found that this presentation misleadingly suggested that Oxtellar XR was approved for treatment of all seizure types. Although the correct indication appeared following the main presentation in scrolling text and a voiceover, OPDP found that this information did not negate the earlier statements. False or Misleading Risk Presentation: OPDP also found that the video included a false or misleading risk presentation because the opening segment consisted of a presentation of the benefits of Oxtellar XR without disclosure of specific risks. The presentation of risks was “relegated to the end of the video,” after the main presentation, where OPDP found it “unlikely to draw the viewer’s attention,” and was displayed in scrolling text with a voiceover. The video was thus found to misleadingly minimize risks by failing to “convey risk information with a prominence reasonably comparable to the claims of effectiveness.” Celgene Untitled Letter (December 2016) OPDP found that a Direct-to-Consumer television advertisement for OTEZLA (apremilast) tablets for oral use (Otezla) made false or misleading representations about the risks associated with the drug. False or Misleading Risk Presentation: The television advertisement at issue had instrumental music playing throughout, including during the major statement of risks. OPDP alleged that a “loud brass interjection” was played over several audio risk disclosures. Moreover, the advertisement included “compelling and attention-grabbing visuals” (e.g., multiple scene changes) and SUPERs during the presentation of risk information. OPDP noted that the visuals were “unrelated to the risk message.” OPDP contended that the scene changes and other competing modalities competed for consumers’ attention, undermining the communication of the important risk information. Because the “overall effect” undermined the communication of important risk information, OPDP concluded that the advertisement misleadingly minimized the risks associated with Otezla. Sanofi-aventis Untitled Letter (December 2016) OPDP contended that a Direct-to-Consumer television advertisement for TOUJEO (insulin glargine injection) U-300 for subcutaneous use (Toujeo) made false or misleading representations about the risks associated with the drug. False or Misleading Risk Presentation: The television advertisement at issue communicated risk information through audio and on-screen SUPERs. However, during the presentation of risk information, the advertisement showed fast-paced visuals unrelated to the risk information, frequent scene changes, and “competing modalities” such as background music. OPDP found that these factors would make it challenging for consumers to adequately process and comprehend the risk information. Because the “overall effect” undermined the communication of important risk information, OPDP concluded that the advertisement misleadingly minimized the risks associated with Toujeo. 11
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2016 End-of-Year Summary of FDA Advertising and Promotion Enforcement Activity

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